Borderline Personality DisorderPhase 2MDMA in BPDNCT06683014
MDMA in Borderline Personality Disorder
A Phase 2 study testing MDMA in people with Borderline Personality Disorder, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to test the effects of MDMA (3,4-methylenedioxymethamphetamine) on social cognition in adults with Borderline Personality Disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- MDMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2025to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults between the ages of 18-60 years
- Body weight between 110 and 210 pounds. Minimum body mass index (BMI) 16.5.
- Able to swallow pills.
- Must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable and must sign release of information for this contact person.
- Must reside within 200 miles (or within a 4-hour commute) to the Connecticut Mental Health Center (CMHC) in New Haven.
- People of childbearing potential must agree to utilize a highly effective method of birth control (including the following, in accordance with Clinical Trials Facilitation and Coordination Group (CTFG) guidelines: combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation, including oral, intravaginal, and transdermal administrations; estrogen-only hormonal contraception associated with inhibition of ovulation, including oral, injectable, and implantable forms; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; abstinence from sexual activity with biological males) and for one month prior to dosing and for the duration of the two week follow-up period.
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- Able to provide written informed consent according to Yale IRB guidelines.
- Able to read and write English proficiently.
- Diagnosis of BPD, as determined by the Diagnostic Interview for Personality Disorders BPD questions (DIPD), including endorsement of the criteria for abandonment fears and for stormy relationships.
- No exposure to MDMA in the last 6 months, and no more than 10 lifetime uses of ecstasy.
- Agree not to drive a motor vehicle for 24 hours after the treatment day. Agree to identify a support person to accompany them home after the medication day.
- Are willing to remain overnight at the study site after each experimental session until the next morning if recommended by the study physician
- Currently not taking contraindicated medications (antidepressants, antipsychotics, mood stabilizers, stimulants).
- Medications not on the contraindicated list must be reviewed and approved by the study PI
- For people in mental health care, signs releases for the study investigators to communicate with their mental healthcare provider and medical doctor(s) about their medical and mental health history and their mental and medical status during the study. When contacted, the mental healthcare provider confirms the ongoing treatment relationship.
- For people not in mental health care acknowledges receipt of local resources for mental healthcare.
- For all participants, acknowledges receipt of local emergency resources
Who cannot join
- History of bipolar disorder, schizophrenia or schizoaffective disorder or currently exhibiting psychotic features as determined by the Structured Clinical Interview for DSM5 (SCID-5) and/or clinician assessment.
- Lifetime diagnosis of autism.
- Serious suicide risk in the past 6 months, as assessed by Columbia Suicide Severity Rating Scale (CSSRS) type 4 or 5 ideation, or suicidal behavior (CSSRS item) or preparatory acts (CSSRS item).
- Any current substance use disorder (in the last 1 month) per SCID interview for alcohol or non-alcohol substances; or a positive pre-study (screening) urine drug screen.
- Any severe substance use disorder during the last 6 months.
- Any significant history of serious medical or neurological illness (including history of stroke, myocardial infarction, heart failure, cardiac arrhythmia, diabetes, family history of long-QT syndrome, etc.)
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- Any signs of major medical or neurological illness on examination, ECG screening, or laboratory tests. For QTc, we would exclude for QTcf >450. For liver function tests (AST, ALT), we will exclude for values more than 2.5 times the upper limit of normal range for our laboratory. For kidney function, we would exclude for eGFR < 90 (n.b. our laboratory does use the contemporary non-race based formula for eGFR). Clinically significant electrolyte imbalances (sodium, potassium values out of range) will also be exclusionary (clinical significance to be determined by study MD review). A participant with a clinical abnormality may be included only if the study physician considers the abnormality will not introduce additional risk factors and will not interfere with the study procedure.
- History of valvulopathy or pulmonary hypertension (due to evidence of 5HT2B receptor agonism by MDMA)
- History of uncontrolled hypertension with baseline blood pressure above 130 mmHg (systolic) and over 90 mmHg (diastolic). Any history of syncope and/or study baseline blood pressure below 90 mmHg (systolic).
- History of tachycardia with baseline heart rate above 90 beats per minute.
- Current pregnancy or breastfeeding as assessed by patient report or by urine pregnancy test.
- Taking any contraindicated medications: antidepressants, mood stabilizers, antipsychotics, stimulants. No patient will be encouraged to discontinue medications for the study. We will allow people to participate who stopped contraindicated medications at least five half-lives before baseline assessments.
- Hypersensitivity to non-MDMA ingredients of the investigational medicine product (IMP), namely mannitol, magnesium stearate, and hydroxypropylmethylcellulose.
- Herbal and dietary supplements will be reviewed on a case-by-case basis by the sponsor-PI for decision about safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
Official title: The Effects of MDMA (3,4-methylenedioxymethamphetamine) in Social Cognition in Borderline Personality Disorder
The purpose of this study is to test the effects of MDMA (3,4-methylenedioxymethamphetamine) on social cognition in adults with Borderline Personality Disorder.
- Conditions
- Borderline Personality Disorder
- Being tested
- MDMA
- Keywords
- 3,4-methylenedioxymethamphetamine, social cognition
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDMADrug
Also called 3,4-methylenedioxymethamphetamine
Participants will receive one dose of open-label 3,4-methylenedioxymethamphetamine (MDMA).
| Study group | Role | What they receive |
|---|---|---|
| Open-Label MDMA | Experimental | Participants will receive one dose of open-label 3,4-methylenedioxymethamphetamine (MDMA). Receives: Drug: MDMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-Reported Social Cognition After 1 Dose of MDMA.
Defined as sociability visual-analogue scale (VAS) score. Total score range is 0-100, higher scores indicating more sociability.
Measured: From baseline (immediately before drug dose) to 2 hours after drug dose on the same day.
Secondary outcomes (1)
Change from baseline in emotion appraisal on facial emotion recognition task score, on same day after drug administration.
The facial-emotion recognition task is a computer-based cognitive task for measuring ability to recognize facial emotions, that yields accuracy scores for positive and negative emotions. Possible scores range from 0 (poor facial emotion recognition) to 100% (excellent facial emotion recognition).
Measured: From baseline (immediately before drug dose) to 2 hours after drug dose on the same day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start5 Sep 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Connecticut Mental Health Center
- Responsible party
- Principal investigator, Sarah Fineberg, Yale University
- Investigators
- Sarah K Fineberg, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683014
- Sponsor's protocol ID
- 2000037769
- Acronym
- MDMA in BPD
- Status last verified
- Oct 2026
- First submitted
- 7 Nov 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Currently there is no plan to share to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of MDMA (3,4-methylenedioxymethamphetamine) in Social Cognition in Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT06683014
- Acronym / sponsor ID
- MDMA in BPD / 2000037769
- Conditions
- Borderline Personality Disorder
- Keywords
- 3,4-methylenedioxymethamphetamine, social cognition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Connecticut Mental Health Center
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effects of MDMA (3,4-methylenedioxymethamphetamine) on social cognition in adults with Borderline Personality Disorder.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label MDMA | Experimental | Drug: MDMAParticipants will receive one dose of open-label 3,4-methylenedioxymethamphetamine (MDMA). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Adults between the ages of 18-60 years
- Body weight between 110 and 210 pounds. Minimum body mass index (BMI) 16.5.
- Able to swallow pills.
- Must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable and must sign release of information for this contact person.
- Must reside within 200 miles (or within a 4-hour commute) to the Connecticut Mental Health Center (CMHC) in New Haven.
Key exclusion criteria (14 listed)
- History of bipolar disorder, schizophrenia or schizoaffective disorder or currently exhibiting psychotic features as determined by the Structured Clinical Interview for DSM5 (SCID-5) and/or clinician assessment.
- Lifetime diagnosis of autism.
- Serious suicide risk in the past 6 months, as assessed by Columbia Suicide Severity Rating Scale (CSSRS) type 4 or 5 ideation, or suicidal behavior (CSSRS item) or preparatory acts (CSSRS item).
- Any current substance use disorder (in the last 1 month) per SCID interview for alcohol or non-alcohol substances; or a positive pre-study (screening) urine drug screen.
- Any severe substance use disorder during the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDMAAlso: 3,4-methylenedioxymethamphetamineParticipants will receive one dose of open-label 3,4-methylenedioxymethamphetamine (MDMA). | Drug | Open-Label MDMA |
Primary outcome
Change in Self-Reported Social Cognition After 1 Dose of MDMA.
Time frame: From baseline (immediately before drug dose) to 2 hours after drug dose on the same day.
Defined as sociability visual-analogue scale (VAS) score. Total score range is 0-100, higher scores indicating more sociability.
1 secondary outcome
Change from baseline in emotion appraisal on facial emotion recognition task score, on same day after drug administration.
Time frame: From baseline (immediately before drug dose) to 2 hours after drug dose on the same day.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No. Currently there is no plan to share to share individual participant data.
Related trials for Borderline Personality Disorder
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Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
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Predictors of Clinical Course and Treatment Response in DBT Programmes
Self Harm, Borderline Personality Disorder
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Effectiveness of Enhanced Dialectical Behavior Therapy Skills Training Group for Borderline Personality Disorder
Borderline Personality Disorder (BPD), Dialectical Behavior Therapy
RecruitingObservational study
Long Term Follow-up of Mentalization-Based Treatment: Exploring Variability in Outcomes, Long-term Value and Experiences 10+ Year After Receiving MBT Day Hospital or MBT Intensive Outpatient
Borderline Personality Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah K Fineberg, MD, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MDMA in people with Borderline Personality Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah K Fineberg, MD, PhD ((203) 974-7265, fineberg.lab@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-Reported Social Cognition After 1 Dose of MDMA. (time frame: From baseline (immediately before drug dose) to 2 hours after drug dose on the same day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.